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Last Updated: December 22, 2024

ACTONEL Drug Patent Profile


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When do Actonel patents expire, and when can generic versions of Actonel launch?

Actonel is a drug marketed by Apil and Warner Chilcott and is included in two NDAs.

The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and eighty-two drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.

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Drug patent expirations by year for ACTONEL
Drug Prices for ACTONEL

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Drug Sales Revenue Trends for ACTONEL

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Recent Clinical Trials for ACTONEL

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SponsorPhase
Dong-A ST Co., Ltd.Phase 4
Wake Forest University Health SciencesPhase 3
Weill Medical College of Cornell UniversityPhase 4

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Pharmacology for ACTONEL
Drug ClassBisphosphonate
Paragraph IV (Patent) Challenges for ACTONEL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ACTONEL Tablets risedronate sodium 150 mg 020835 1 2008-08-12
ACTONEL Tablets risedronate sodium 75 mg 020835 1 2007-09-07
ACTONEL Tablets risedronate sodium 5 mg, 30 mg and 35 mg 020835 1 2004-04-23

US Patents and Regulatory Information for ACTONEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ACTONEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-005 Apr 22, 2008 7,718,634*PED ⤷  Subscribe
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 6,165,513*PED ⤷  Subscribe
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 6,465,443*PED ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ACTONEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0998292 CA 2006 00005 Denmark ⤷  Subscribe PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
1175904 2007C/048 Belgium ⤷  Subscribe PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
0998292 PA2006002 Lithuania ⤷  Subscribe PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

ACTONEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ACTONEL

Introduction to ACTONEL

ACTONEL, also known as risedronate sodium, is a medication used in the treatment and prevention of osteoporosis. It is part of the bisphosphonate class of drugs, which are widely used to increase bone mass and reduce the risk of fractures.

Market Size and Growth

The global osteoporosis drugs market, within which ACTONEL operates, is projected to experience significant growth. As of 2022, the global osteoporosis drugs market was valued at USD 8.9 billion and is expected to reach USD 12.12 billion by 2031, growing at a CAGR of 3.5% during the forecast period[1].

Regional Market Performance

North America

North America, particularly the U.S., dominates the osteoporosis drugs market, including ACTONEL. This region's strong medical and healthcare infrastructure, along with substantial investments in healthcare and favorable R&D policies, contribute to its market dominance. The U.S. market is driven by high disposable income, enabling easy access to osteoporosis treatments[4].

Europe

Europe is the second-largest market for osteoporosis drugs, with a CAGR of 3.4% expected during the forecast period. The presence of major pharmaceutical companies like Hoffmann-La Roche Ltd. and Novartis International AG, along with increasing awareness and prevalence of osteoporosis, drives the market growth in this region[1].

Asia-Pacific

The Asia-Pacific region, including countries like China, Japan, and India, is expected to witness significant growth due to an aging population, increased healthcare expenditure, and rising awareness of osteoporosis. China, in particular, is driving market growth with government support for healthcare infrastructure enhancement[4].

Drug Class and Market Share

Bisphosphonates

ACTONEL falls under the bisphosphonate segment, which dominates the global osteoporosis drugs market. Bisphosphonates, including drugs like Fosamax, Boniva, Actonel, Reclast, alendronate, and Zometa, hold the majority share due to their widespread use and the presence of major players investing in R&D for advanced bisphosphonates[1].

Approval and Clinical Trials

ACTONEL has received several FDA approvals that have expanded its market reach:

  • Approval for Men: In 2006, ACTONEL was approved for the treatment of osteoporosis in men, based on a two-year clinical trial that showed significant improvements in lumbar spine bone mineral density and reductions in bone turnover markers[2].
  • Once-a-Week and Once-a-Month Dosing: ACTONEL has been approved in various dosing regimens, including once-a-week (35 mg) and once-a-month (150 mg) doses. These approvals have been based on clinical trials that demonstrated similar efficacy to daily dosing regimens while offering greater convenience to patients[2][5].

Safety and Tolerability

Clinical trials have shown that ACTONEL is generally well tolerated. The most commonly reported adverse events include constipation, back pain, arthralgia, influenza, and nasopharyngitis. These adverse events are comparable to those seen in placebo groups, indicating a favorable safety profile[2][3].

Market Drivers

  • Growing Prevalence of Osteoporosis: The increasing prevalence of osteoporosis, particularly among the geriatric population and postmenopausal women, drives the demand for osteoporosis drugs like ACTONEL[4].
  • R&D Activities: Continuous R&D activities focused on launching new drugs and improving existing ones, such as the approval of new dosing regimens for ACTONEL, contribute to market growth[1].
  • Government Regulations and Awareness: Government initiatives and regulations promoting the use of generic and cost-effective drugs, along with rising awareness among healthcare providers and patients, also fuel the market[4].

Challenges and Restraints

  • Safety Concerns: Long-term use of bisphosphonates, including ACTONEL, is associated with safety concerns such as atypical femur fractures, which can restrict market growth[1].
  • Market Saturation: In regions like North America and Europe, the market is somewhat saturated, leading to slower growth rates compared to emerging markets[1].

Financial Trajectory

The financial trajectory of ACTONEL is closely tied to the overall osteoporosis drugs market. Here are some key financial indicators:

  • Revenue Growth: The osteoporosis drugs market, which includes ACTONEL, is expected to grow from USD 8.9 billion in 2022 to USD 12.12 billion by 2031, at a CAGR of 3.5%[1].
  • Generic Competition: As patents for branded drugs like ACTONEL expire, generic versions are becoming more prevalent, which can impact the revenue of branded drugs but also provide cost-effective alternatives to patients[4].

Key Takeaways

  • Market Growth: The osteoporosis drugs market, including ACTONEL, is expected to grow significantly driven by increasing prevalence and R&D activities.
  • Regional Performance: North America and Europe are dominant markets, while Asia-Pacific is expected to show rapid growth.
  • Safety and Efficacy: ACTONEL has a favorable safety profile and has been approved in various dosing regimens.
  • Challenges: Safety concerns and market saturation in certain regions are key challenges.

FAQs

Q: What is the current market size of the osteoporosis drugs market? A: The global osteoporosis drugs market was valued at USD 8.9 billion in 2022[1].

Q: What is the expected CAGR for the osteoporosis drugs market? A: The market is expected to grow at a CAGR of 3.5% from 2023 to 2031[1].

Q: Which region dominates the osteoporosis drugs market? A: North America, particularly the U.S., dominates the market due to its advanced healthcare infrastructure and high disposable income[4].

Q: What are the common adverse events associated with ACTONEL? A: Common adverse events include constipation, back pain, arthralgia, influenza, and nasopharyngitis[2][3].

Q: Why is the Asia-Pacific region expected to show significant growth in the osteoporosis drugs market? A: The region is driven by an aging population, increased healthcare expenditure, and rising awareness of osteoporosis, particularly in countries like China and Japan[4].

Sources:

  1. Straits Research: Osteoporosis Drugs Market Size to Reach $12.12 billion by 2031[1].
  2. Sanofi US: The U.S. Food and Drug Administration approves ACTONEL® for treatment to increase bone mass in men with osteoporosis[2].
  3. BioSpace: P&G, Sanofi Aventis: The U.S. Food And Drug Administration Approves ACTONEL with Calcium[3].
  4. Grand View Research: Osteoporosis Drugs Market Size And Share Report, 2030[4].
  5. Sanofi US: FDA Approves New Once-A-Month Dose Of ACTONEL®[5].

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